Cardiovascular DiseasesNCT05318911
Antithrombotic Activities of a Novel Yogurt Drink
A study testing Novel yogurt drink in people with Cardiovascular Diseases, run by University of Limerick at 1 site in Ireland.
Trial summary
This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Novel yogurt drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 1 May 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
Who cannot join
- Volunteers need to be off medication and off any dietary supplements.
- Subjects must not have any blood clotting disorders or dyslipidaemia.
- Dairy intake needs to be within a normal range of 1-2 portions a week.
- Unwilling to follow the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study
This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers
Read the detailed description
This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease.
In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.
- Conditions
- Cardiovascular Diseases
- Being tested
- Novel yogurt drink, Placebo Drink
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel yogurt drinkDietary supplement
Novel ovine yogurt drink containing polar lipids
Placebo DrinkOther
Placebo drink (skimmed milk)
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Active comparator | 10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of novel yogurt drink per day for a period of 28 days.
Then, after a 2-week washout period in which the subjects do not take any yoghurt drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis. Receives: Dietary Supplement: Novel yogurt drink |
| Placebo Group | Placebo comparator | 10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of placebo drink per day for a period of 28 days.
Then, after a 2-week washout period in which the subjects do not take any placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis. Receives: Other: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation of PRP samples in the presence of PAF
Platelet aggregation of participants' platelet-rich plasma samples (PRP) in the presence of the platelet agonist PAF will be assessed, using EC50 as a parameter.
Measured: Participants' platelet activity will be assessed for up to roughly 6 months through study completion
Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL).
Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed.
Measured: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Screening plasma levels of inflammatory markers.
Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened.
Measured: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Screening plasma levels of triglycerides.
PRP levels of triglycerides will also be screened.
Measured: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 May 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Zabetakis, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318911
- Sponsor's protocol ID
- 2022_01_01_S&E
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsoupras A, Zabetakis I, Lordan R. Platelet aggregometry assay for evaluating the effects of platelet agonists and antiplatelet compounds on platelet function in vitro. MethodsX. 2018 Dec 26;6:63-70. doi: 10.1016/j.mex.2018.12.012. eCollection 2019.
PubMed 30619728
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT05318911
- Acronym / sponsor ID
- 2022_01_01_S&E
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers
Detailed description
This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease.
In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Active comparator | Dietary Supplement: Novel yogurt drink10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of novel yogurt drink per day for a period of 28 days. Then, after a 2-week washout period in which the subjects do not take any yoghurt drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis. |
| Placebo Group | Placebo comparator | Other: Placebo Drink10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of placebo drink per day for a period of 28 days. Then, after a 2-week washout period in which the subjects do not take any placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (4 listed)
- Volunteers need to be off medication and off any dietary supplements.
- Subjects must not have any blood clotting disorders or dyslipidaemia.
- Dairy intake needs to be within a normal range of 1-2 portions a week.
- Unwilling to follow the study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel yogurt drinkNovel ovine yogurt drink containing polar lipids | Dietary supplement | Supplement Group |
| Placebo DrinkPlacebo drink (skimmed milk) | Other | Placebo Group |
Primary outcome
Platelet aggregation of PRP samples in the presence of PAF
Time frame: Participants' platelet activity will be assessed for up to roughly 6 months through study completion
Platelet aggregation of participants' platelet-rich plasma samples (PRP) in the presence of the platelet agonist PAF will be assessed, using EC50 as a parameter.
Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL).
Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed.
Screening plasma levels of inflammatory markers.
Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened.
Screening plasma levels of triglycerides.
Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
PRP levels of triglycerides will also be screened.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 30619728Tsoupras A, Zabetakis I, Lordan R. Platelet aggregometry assay for evaluating the effects of platelet agonists and antiplatelet compounds on platelet function in vitro. MethodsX. 2018 Dec 26;6:63-70. doi: 10.1016/j.mex.2018.12.012. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel yogurt drink in people with Cardiovascular Diseases, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation of PRP samples in the presence of PAF (time frame: Participants' platelet activity will be assessed for up to roughly 6 months through study completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.